About this opportunity
astellas lists this Scientist I - Formulation Development opportunity in california, Missouri. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Scientist I (Formulation Development)
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at
The Role
The primary purposes of the Scientist I, in Formulation & Analytical Development, are to design, evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development, supporting the growing and diversifying portfolio of programs within AGT’s pipeline.
Responsibilities
Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
Author regulatory documents such as IND and briefing documents for meetings with health authorities.; prepare responses to Information Requests from agencies.
Join the technical discussion cross-functional/divisional to align and enable efficient drug development work
Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately.
Required Qualifications
Advanced degree in biology or engineering with 5+ years of relevant experience in the biopharmaceutical industry
Experience in formulation development for biopharmaceutical products
Positive, professional attitude with a passion for science
Business-level proficiency in English
Preferred Qualifications:
Experience in authoring IND, BLA or other related regulatory filings, and responding to agency feedback/inquiries
Experience with process development and technology transfer to GMP facilities for drug product manufacturing process
Experience in operating basic analytical tools, such as chromatography and electrophoresis
Experience working with external vendors, institutions, and other collaborators to develop new and innovative technologies
Working Environment
This position is based in Japan or US and will require on-site work.
Salary Range
$91,000 - $130,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company-paid fleet vehicle for eligible positions
Referral bonus program
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.